General Purpose Reagent
- US Product Code (FDA)
- PPMView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 864.4010View CFR Regulation →
- Medical specialty
- Pathology
- GMP exempt
- Yes
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
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General Purpose Reagent is a medical device type in the Pathology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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